Effectiveness of NOA OATMAD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- AHI
研究概览
简要总结
This study is looking at how well the OrthoApnea NOA appliance, a special custom-made mouthpiece, helps treat people with obstructive sleep apnea (OSA). OSA is a common sleep problem where a person's breathing starts and stops many times during the night. Some people find it hard to use the usual treatment, called a continuous positive airway pressure (CPAP) machine, so this mouthpiece might be an easier and more comfortable option. The study is also checking if a small tool called the Morning Aligner, worn briefly in the morning, can help move the jaw back to its normal position. This might help people feel better and reduce side effects.
The study will last for three years. During this time, researchers will watch how people do while using the OrthoApnea NOA and compare their results to those of other people who used different types of plastic mouthpieces. The main goal is to see if the NOA can cut the number of times a person stops breathing during sleep by at least half. They hope to reduce it to fewer than 5 times an hour, which is close to normal. They will also check other things like how much oxygen people get while sleeping, their weight, how sleepy they feel during the day, how comfortable the mouthpiece is, how long it lasts, and how often people keep using it.
Instead of picking who gets which mouthpiece at random, this study uses a different method. It compares new patients using the NOA to past patients who used other mouthpieces. This is more like what happens in real life at clinics. By studying both new and past data, the researchers hope to better understand how the NOA works over time and how it compares to other options. This information will help dentists, sleep doctors, and patients choose the best way to treat sleep apnea using mouthpieces.
详细描述
Research Proposal: Evaluating the Effectiveness of the OrthoApnea NOA Dental Appliance in Treating Obstructive Sleep Apnea (OSA)
- Purpose of the Study This study will evaluate how effective the OrthoApnea NOA dental appliance is at treating patients with mild, moderate, and severe obstructive sleep apnea (OSA). It will also assess the Morning Aligner as a supporting tool to maintain jaw alignment and comfort.
In addition to following patients prospectively over three years, this study will also analyze and compare pre-existing clinical data from other patients who have used different nylon-based mandibular advancement devices. This approach will allow us to assess relative performance in terms of treatment outcomes, comfort, and long-term adherence. 2. Hypothesis The OrthoApnea NOA, used with the Morning Aligner, will reduce the Apnea-Hypopnea Index (AHI) by at least 50%, with a goal of bringing AHI to fewer than 5 events per hour in many patients.
Compared to other nylon-based dental appliances, the NOA will show:
Better long-term efficacy
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dxed OSA being treated with NOA appliance
排除标准
- •no OSA Dx
结局指标
主要结局
AHI
时间窗: 3 years
Disease Index
次要结局
- Side Effects(3 years)
